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Updated: Nov 5, 2025
08:46
A Neonatal Imaging Model of Gram-Negative Bacterial Sepsis
Published on: August 12, 2020
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Antibiotic regimens for early-onset neonatal sepsis
Steven Kwasi Korang1, Sanam Safi1, Chiara Nava2
1Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region of Denmark, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
The Cochrane Database of Systematic Reviews
|May 17, 2021
Summary
Neonatal sepsis, a leading cause of infant death, lacks sufficient evidence to determine the best antibiotic treatment. More high-quality trials are needed to compare different antibiotic regimens for early-onset neonatal sepsis.
Area of Science:
- Neonatal Medicine
- Infectious Diseases
- Pharmacology
Background:
- Neonatal sepsis is a significant global cause of infant morbidity and mortality.
- Despite its impact, high-quality evidence for optimal diagnosis and treatment is limited.
- Antibiotics are widely used in neonatal intensive care units for suspected sepsis.
Purpose of the Study:
- To systematically review and assess the benefits and harms of various antibiotic regimens for early-onset neonatal sepsis.
- To update previous reviews given the clinical importance and evolving treatment landscape.
Main Methods:
- Searched multiple electronic databases and clinical trial registries for randomized controlled trials (RCTs) and quasi-RCTs.
- Included RCTs comparing different antibiotic regimens in neonates up to 72 hours old.
- Assessed study inclusion, data extraction, and risk of bias independently; used GRADE for evidence certainty.
Main Results:
- Five RCTs with 865 participants were included, all with a high risk of bias and very low certainty of evidence.
- No significant differences were found in all-cause mortality or other key outcomes across the five antibiotic comparisons.
- Lack of well-powered trials and high risk of bias mean the comparative benefits and harms of antibiotic regimens remain unclear.
Conclusions:
- Current evidence is insufficient to recommend one antibiotic regimen over another for early-onset neonatal sepsis.
- Large, high-quality RCTs with low risk of bias are urgently needed to guide treatment decisions.
- Further research is essential to clarify the optimal antibiotic strategies for this vulnerable population.
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